Stem Cell Research: A Science and Policy Overview

1. An Introduction to Stem Cells
1. An Overview of Stem Cells
2. Cloning
3. Case Study: Junvenile Diabetes and Stem Cell Research
2. American Stem Cell Research Policy
1. American Stem Cell Research: Politics and Policies
2. State Cloning Legislation
3. World Stem Cell Policies
1. Overview of World Human Cloning Policies
2. World Cloning Policies
4. Glossary
9. Contact Us

An Overview of Stem Cells

Overview

Stem cells are cells that have the potential to replicate themselves for
indefinite periods and to divide, producing one copy of themselves and one
cell of a different type (differentiation). In humans, stem cells have been
located in: the early stages of development after egg fertilization (around 5-
6 days); the umbilical cord and placenta; and in several adult organs.

Regardless of their source all stem cells have two general properties:

e Stem cells are capable of dividing and renewing themselves for long
periods. Unlike muscle cells, blood cells, or nerve cells — which do not
replicate themselves — stem cells can divide continuously and keep
their innate properties.

e Stem cells are undifferentiated and can give rise to multiple cell-types.
Stem cells do not have any tissue-specific structures that allow them to
perform specialized functions. They cannot carry molecules of oxygen
through the bloodstream like red blood cells or release signals to other
cells, such as permitting the body to move or speak, as nerve cells do.
Although stem cells do not have any tissue-specific structures, they
can give rise to differentiated cells, including red blood cells and nerve
cells.

Stem cells have varying abilities to differentiate into different cell-types
(see Figure 1). One type of stem cell can give rise to any other cell-type of a
given organism (for example, an embryonic stem cell). Other stem cells can
only give rise to cells of a given tissue type (for example, bone marrow can
produce blood stem cells) or only give rise to a few cell-types in a given
tissue.

Scientists are just beginning to understand the signals in a body which can
trigger cell differentiation. These signals can be created within a cell,
triggered by a cell’s genes, or by a neighboring cell that releases chemicals
to promote differentiation in other cells. Determining what these signals are
and what stem cells require to differentiate into different cell-types is a

crucial research area which must be explored in order to utilize stem cells
for therapies.

When cells differentiate, their abilities become more restricted. They often
follow only a few prescribed pathways and can lose the capacity to replicate
themselves. The ability of stem cells to replicate and remain unspecialized
until they are needed is an important area of research vital to understanding
human development.

Stem cells offer a new look at old problems and diseases such as burns and
diabetes. Although the field is relatively new, the impact of new discoveries
could profoundly change medical research and therapy. Many of these new
approaches involve the use of somatic cell nuclear transfer (sometimes
known as therapeutic cloning) to produce recipient-specific tissue by
creating embryonic stem cell lines.

This new area of research has great potential, but it is not without its
controversies. Many ethical dilemmas are produced with the creation and
destruction of human blastocysts as well as the potential to clone an entire
human being (reproductive cloning). No matter where society designates
the boundary to be for this research, or whether or not stem cells can live up
to our high expectations, a great deal can be learned through careful and
thoughtful studies.

The Potential Uses of Embryonic Stem Cells

Embryonic Stem Cells

Embryonic stem cells are derived exclusively from a fertilized egg that has
been grown in vitro for 5 to 6 days to form a blastocyst. Within a
blastocyst there is a small group of about 30 cells called the inner cell
mass, which will give rise to the hundreds of highly specialized cells
needed to make up an adult organism. Embryonic stem cells are obtained
from this inner cell mass. For research purposes, embryonic stem cells are
produced specifically from eggs that have been fertilized in vitro, or ina
laboratory and not inside a woman’s body, or in vivo. Embryonic stem cells
can come from a frozen fertilized egg or an egg which is fertilized in vitro.

Embryonic stem cells can and do differentiate into all the specialized cells
in the adult body. They could be induced to provide an unlimited source of

specific and clinically important adult cells such as bone, muscle, liver or
blood cells (See Figure 2).

Cell-Types Embryonic Stem
Cells* Have Been Grown Into

Smooth Muscle
Heart Muscle
Nerves

Bone
Cartilage

Kidney

Red and Vvhite Blood Cells
Pancreas

Liver

Yolk Sac

Lymph Nodes

Endoderm

Adult Stem Cells

Adult stem cells are unspecialized or undifferentiated cells found among
specialized cells in an adult tissue or organ. In some adult tissues, such as in
bone marrow, muscle, or brain tissue, discrete populations of adult stem
cells generate replacements for cells that are lost through disease, injury, or
normal wear and tear. Adult stem cells are thought to reside in an area of
each tissue where they may remain quiescent, or non-dividing, for many
years until they are activated by disease or tissue injury. Where they are
found, adult stem cells consist of a very small population of cells within
each tissue.

Some adult stem cells retain the ability to form into specialized tissues other
than the one from which they originated. For example, blood
(hematopoietic) cells have not been proven to differentiate into nerve,
skeletal muscle, cardiac muscle, or liver cells (see Figure 3). There is some
evidence that brain stem cells can differentiate into blood or skeletal muscle
cells. However, adult stem cells have a limited number of tissues they can

differentiate into and do not have the same potential as embryonic stem
cells to become any cell-type.

The environment that adult stem cells grow in has an important, but poorly
understood, effect on their fate. The relationship between the adult stem cell
environment and its ability to differentiate into other cell-types has also not
been fully explained.

Cell-Types
Adult Stem Cells*
Have Been Grown Into

Red and ¥Yhite Blood Cells
Skin

Fat

Smooth Muscle
Heart Muscle
Skeletal Muscle
Liver

Digestive Tract
Nerves
Cartilage
Pancreas
Cornea

Distinctions between Embryonic and Adult Stem Cells

Most importantly, adult and embryonic stem cells differ in the type of
differentiated cells they can become. While embryonic stem cells can be
induced to differentiate into any cell-type, adult stem cells cannot. Most
adult cells can only differentiate into the types of cells found in their
environment or in the particular tissue or organ where they reside.
Therefore in many vital organs, adults do not have the stem cells necessary
to regenerate damaged areas; thus scar tissue will develop instead.

Another key difference between embryonic and adult stem cells is the
volume of cells one can isolate and grow in vitro. Large numbers of
embryonic stem cells can be grown in vitro from a single blastocyst. On the
contrary, adult stem cells are rare and methods of growing them still need to

be perfected. In addition, due to their limited numbers, it is difficult to
isolate a group of adult stem cells in pure form, without having them
contaminated with differentiated cells.

Potential Uses of Stem Cells

Stem Cell Research Could Potentially Help:

Parkinson's Alzheimer's Burns

Spinal cord injury Stroke Heart Disease
Diabetes Osteoarthritis Infertility

Rheumatoid arthritis Birth Defects Pregnancy Loss
Leukemia Brain Cancer Muscular Dystrophy
Sickle Cell Anemia Brain Trauma/Damage Liver Disease
Metabolic Disorders Deafness Macular Degeneration
Retinitis Pigmentosa Organ Donation

Stem Cells

While stem cell research is in its infancy and many of its proposed uses are
hypothetical, the research has generated excitement among many scientists
for its potential. One of the vital components of ongoing work is
understanding the very nature of these cells; that is, to determine the
conditions necessary to maintain undifferentiated stem cells as well as
differentiating them along specific pathways. In order to truly determine
whether or not these cells can be used therapeutically, more research must
be conducted to understand the nature of the cells.

Although we are only beginning to discover what stem cells are capable of
doing, scientists have proposed several potential uses.

1. Abnormal Cell Division. Many serious medical conditions, such as
cancer and birth defects, are due to abnormal cell divisions or the
inability of cells to turn themselves on and off properly. Having a
better understanding of stem cells and their genetic and molecular
controls would yield information about diseases and reveal potential
strategies for therapies.

. Drug Testing. Stem cells could be used to test new drugs or
medications by differentiating them to the particular cell-types that the
drugs are targeting. This would offer a short-cut for scientists to sort
out chemicals that can be used to treat diseases. By testing new drugs
on stem cell lines, we could perform rapid screening of hundreds of
thousands of chemicals that now are tested by more time-consuming
processes. This could also potentially decrease the time that it takes to
get a drug to market.

. Cell-Based Therapies. Stem cells could be used for cell-based
therapies. Stem cells could be directed to differentiate to a specific
cell-type that then could be used as a renewable source of replacement
cells and tissues. In order to be useful for cell-based therapies, stem
cells must be made to:

Differentiate into desired cell-types. It is necessary for stem cell
techniques to be improved until they can consistently and efficiently
differentiate into a specific cell or type of cells without contamination
by undifferentiated or improperly differentiated cells.

Proliferate extensively and generate sufficient quantities of tissue. The
protocols for differentiating stem cells need to be refined so that large
quantities of tissue can be produced in a relatively efficient manner.

Survive in the recipient after the transplant. Scientists must determine
that the cells are healthy and viable after transplantation. They also
should establish that the stem cells are localized to the correct tissue in
the recipient.

Function appropriately for the duration of the recipient’s life. Not only
do the cells need to be localized and survive, but they must also
behave like the original cells. Currently, there is not sufficient data
showing that stem cells are functional in their new environment when
they are transplanted into organs. For cell-based therapies to be
successful, the new cells need to function correctly and interact
properly with the original tissue.

Avoid harming the patient in any way. One concern about using
undifferentiated cells or stem cells is the risk of the stem cells having

genetic abnormalities which could cause them to be cancerous or to be
rejected due to tissue immune incompatibility. Adequate testing is
necessary to make sure the cells used are healthy.

Embryonic Stem Cells

One of the most promising uses for embryonic stem cells is the study of the
complex events that occur during human development. The earliest stages
of human development have previously been difficult or impossible to
study. By using embryonic stem cells, these studies can be performed with
the goal of preventing or treating birth defects, infertility, and pregnancy
loss.

The use of embryonic stem cells can also help scientists identify how
undifferentiated cells become differentiated. Since these cells have the
ability to become any type of cell in the adult body, they have a larger
potential for medically viable tissues which can be derived and used in cell-
based therapies.

References and Further Suggested Readings

1. International Society for Stem Cell Research: http://www.isscr.org

2. NIH, Stem Cell Basics: http://stemcells.nih. gov/info/basics/

3. National Research Council and Institute of Medicine. (2002) Stem
Cells and the Future of Regenerative Medicine. Washington D.C.::
National Academy Press: http://www.nap.edu.

4. Embryonic Stem Cell Research at the University of Wisconsin-

Madison: http://(www.news.wisc.edu/packages/stemcells/facts.html#1

. National Parkinson Foundation: http://www.parkinson.org.

. Juvenile Diabetes Research Foundation: http://www.jdrf.org.

7. Wilmut, I., et. al. (1997) Viable Offspring Derived from Fetal and
Adult Mammalian Cells. Nature 385:810-13.

OQ Ul

To contact us, please visit our contact page.

Cloning

Cloning

Somatic cell nuclear transfer (SCNT) is when the genetic material
(nucleus) of an unfertilized egg is removed and replaced with the genetic
material of a normal cell. The egg is then activated and allowed to grow.
After it is allowed to grow into a blastocyst, embryonic stem cells are
obtained from the inner cell mass. These embryonic stem cells can then be
induced to become other differentiated cell-types. (See Figure 1)

Much of the promise for embryonic stem cells lies in the potential of
deriving or creating cell lines which are specific to a person. This technique
can be used to create cell lines and study the development of different
diseases (sometimes called therapeutic cloning). For instance, by using a
skin cell from a patient suffering with Parkinson’s disease one could create
a cell line that would show the researcher how the cell progressed from a
normal to a diseased state. Not only could scientists study specific genetic
diseases, but they could also create tissues that are compatible with the
original donor.

Further, this technique can also be used to create tissues that are recipient-
specific. In organ and tissue transplantation, a great concern is the rejection
of transplanted tissue by the recipients’ immune system. If new cell lines
were created to be identical to the recipient, this would no longer be a
problem.

Somatic Nuclear Cell Transfer

Unfertilized '

Egg Donor Patient

Nucleus Removed
from Egg Cell

Genetic Material
from a normal cell
(c.g. a skin cell)
replaces egg’s
nucleus

Embryonic
Stem Cells ,
Embryonic Stem
Cells are obtained

5-6 days from inner cell mass
of blastocyst.

Blastocyst

Reproductive Cloning is when an egg undergoes somatic cell nuclear
transfer and the resulting cell is allowed to grow to an infant that is an exact
genetic copy of the somatic cell donor. Attempts at reproductive cloning
have been error-prone and inefficient, resulting in the failure of most clones
to develop. The most famous clone, Dolly (a sheep), was only created after
multiple attempts and failures and then lived a shortened life (Wilmut et al,
1997).

Another option for creating stem cells without using egg cells has been
discovered in mice. When four specific genes are added to a normal cell
(such as a skin cell) the cell become deprogrammed, and regains its ability
to be differentiated into many different types of tissue and to divide
indefinitely. This innovative procedure has problematic aspects though; one
of the necessary genes contributes to cancer in some of the mice studied,
and genes are introduced into the skin cells by way of a retrovirus, which
may also cause adverse effects in any tissue cultures grown using this

method. However, if this procedure were ever adapted to human cells, the
issue of immune rejection of grafted tissue would be eliminated, as the stem
cells are genetically identical to the donor cells.

To visit us, please visit our contact page.

Case Study: Junvenile Diabetes and Stem Cell Research

Case Study: Juvenile Diabetes and Stem Cell Research

Juvenile diabetes, also known as type 1 diabetes, is essentially an
autoimmune disease where one’s own body starts attacking itself. In
juvenile diabetes the body specifically destroys a pancreas cell, the &-cell,
which produces insulin. Insulin is an important hormone that balances
blood sugar levels. Unregulated sugar levels in the blood can lead to severe
problems such as kidney failure, blindness, stroke, and even death. Patients
with juvenile diabetes are required to take multiple injections of insulin
daily or have a continuous infusion of insulin through a pump just to
survive. Also, they must constantly monitor their food intake and daily
activities.

Scientists have been working for years to find a cure and are extremely
optimistic about the potential use of stem cells to replace destroyed f-cells.
In a recently published study using mice, Harvard researchers determined
that new &-cells in the pancreas are formed through the replication of pre-
existing {§-cells, rather than adult stem cells creating new {-cells. These are
the very cells being attacked and therefore their numbers are limited. This
result means that in order to cure juvenile diabetes, scientists must rely on
another source of {-cells, such as embryonic stem cells, to generate new {-
cells.

To contact us, please visit our contact page.

American Stem Cell Research: Politics and Policies

Overview

In February of 1997, Dr. Ian Wilmut announced the creation of the first
cloned mammal. The report, published in the science journal Nature,
described a lamb, "Dolly," which was cloned using somatic cell nuclear
transfer (SCNT). This landmark paper and the media attention it received
created an immediate reaction from the public and politicians in
Washington, D.C. who were concerned about the potential cloning of
humans using this technique. Since Dolly’s creation, congressional leaders
have been trying to find a way to prevent human cloning and other
allegedly unethical medical procedures while still allowing medical
research to proceed unhindered.

In late 1998, the issue was further complicated by the announcement from
researchers at the University of Wisconsin-Madison, led by Dr. James
Thomson, who derived the first human embryonic stem cells from
blastocysts. This marked the beginning of a new area of medical science,
human embryonic stem cell research. With this new breakthrough, the issue
of human cloning became considerably more complex, since SCNT was
now linked to potential disease-curing research.

With each congressional session, a new crop of conflicting bills arises from
both the House and the Senate, and congressional hearings are called to
bring witnesses in to validate either side, but no resolution appears to be in
sight. Although many polls have shown that the vast majority of Americans
disapprove of research which could produce a cloned human (79% in a
2005 poll by Research! America), there is still much public debate about the
ethics of embryonic stem cell research. This debate resonates in the
Congress and generates the current stalemate where lawmakers are unable
to reach a consensus about medical research relating to embryonic stem
cells.

Pre-“Dolly” Regulation

In the 1970s, rules were developed to govern the federal funding of research
on human embryos for in vitro fertilization (IVF). The rules specified that
all federally funded research on human embryos would need to be
approved by a congressionally appointed ethics advisory board. Although
the board met once, it was dissolved in 1980 without ever federally funding
embryonic research. In 1993, this rule was rescinded, but the Dickey
Amendment, a Department of Health and Human Services (DHHS)
1996 appropriation rider, subsequently banned any federal funding of
human embryo research and each year this amendment has been attached to
the appropriation bill for the DHHS. Since that time, no federal funds have
been allowed for embryo (and therefore embryonic stem cell) research, but
private funding of research on embryos has been allowed and is completely
unregulated.

Post-“Dolly” Debate

In February of 1997 after the public announcement about “Dolly”, President
Clinton charged the National Bioethics Advisory Council (NBAC) to
study the issue of human cloning. In June of that year, NBAC released a
report which determined that reproductive cloning was immoral and
requested that a moratorium should be established until subsequent laws
prohibiting it were passed (with a sunset period of 3-5 years). The members
also suggested that the law be written so it would not interfere with
biomedical research. Taking their suggestions, President Clinton offered a
legislative proposal to bar anyone (either federally or privately funded)
from attempting to clone a human through SCNT for 5 years. President
Clinton’s proposal was announced after several bills in the House and
Senate had already been introduced (see Table 1). However, due to the fear
that Congress was acting too quickly and might bar valid research, the
majority needed to pass these bills was never attained and thus no
legislation limiting such cloning was ever successfully passed into law.
Table I-Bills From 106th Congress

Bill Sponsor Action

5. 368 Sen, Bond (R-MO) The government would be permanently banned against
using federal funds for cloning an individual.
H.R. 922 Rep. Ehlers (R-Ml) Human Cloning Research Prohibition Act

The government would be permanently banned against
using federal funds for cloning an individual.

H. Doc 105-97 Pres. Clinton The Cloning Prohibition Act of 1997.
It would bar everyone in the country, both private and
publicly funded, from attempting to create a baby through
SCNT. The act would only last five years. It would fine
anyone who violated the act $250,000.

58.1574 Sen. Campbell (R-VWY) Human Cloning Prohibition Act
The bill would bar federal funding of research designed
to clone a human or create a human embryo. It would
fine violators $5000.

5. 368 Sen, Bond (R-MO} Human Cloning Prohibition Act.
The government would be permanently banned against
using federal funds for cloning an individual. It would
make the creation of a human embryo through SCNT a
criminal act with a 10 year prison sentence. It would also
prohibit importing human embryos which were created
by SCNT and create a National Commission to promote
a national dialogue on bioethics.

5.1602 Sen. Feinstein (D-CA) Prohibition of Cloning Human Beings Act of 1998.
Sen. Kennedy (D-MA) The bill would forbid the creating of a human by SCNT
and bar federal funding for 10 years. Violators would be
fined $1 million.

In November of 1998, after Dr. Thomson announced the creation of the first
human embryonic stem cell line, President Clinton asked NBAC to
specifically address human embryonic stem cell research, which had not
been discussed in 1997. In 1999, the NBAC recommended that federal
funding should be used to support both the research and creation of human
embryonic stem cells. They also suggested amending the ban on embryo
research (the Dickey Amendment) to allow the derivation and use of
embryonic stem cells.

However, before the results of the NBAC deliberations were announced, the
National Institutes of Health (NIH), specifically the legal council for the
DHHS, determined that federal law (the Dickey Amendment) prohibited the
use of federal funds to create human embryonic stem cell lines, but they did
believe that it was legal to fund research on already existing lines. Private
sources were never barred from deriving their own human embryonic stem
cell lines and were actively pursuing this area of research. The NIH released

guidelines for the federal funding of human embryonic stem cell research
for public comment in 1999, followed by an updated version in 2000 in the
Federal Register. Before NIH was able to grant money in response to
research proposals, a new administration (President George W. Bush) took
office and the previous rulings by the DHHS and NIH were set aside.

Meanwhile in the Senate, the Specter-Harkin bill (S.2015) was introduced
as the Stem Cell Research Act of 2000. It called for the federal funding of
the derivation and use of human embryonic stem cells from spare donated
embryos (IVF), as long as the research did not lead to "reproductive cloning
of a human being.” This marked the first of many bi-partisan bills that
Congress would see on this issue. The Specter-Harkin bill, like many future
bills, was not passed into law.

When President Bush took office, one of his first actions was to temporarily
stop all federal funding of human embryonic stem cell research (no grant
had been given) while his administration considered their actions. On
August 9, 2001, after several months of deliberation, President Bush
announced that he would allow the federal funding of the research of
human embryonic stem cells, but only those that had been derived before
the date of the announcement could be used. Thus, no new embryonic stem
cells could be created with federal funds, nor could federal funds be used to
do research on new lines create after the August 9, 2001 deadline. NIH
estimated at the time that there were as many as 60-75 cell lines available
for research. However, since that time, NIH has revised its numbers
downward. By the 2004 presidential campaign, NIH had only 22 lines
available (see insert “Effect of President Bush’s Stem Cell Policy”).

Since the President’s August 9, 2001 decision, embryonic stem cell policy
has remained unchanged. In November 2001, President Bush established
the President’s Council on Bioethics (PCB), a group of experts (similar
the NBAC), to address the issues of human cloning, embryonic stem cell
research and other bioethical issues. In Congress, new bills were introduced
in the 107th and 108th congress, and the Weldon-Stupak bill was passed in
House in 2001 and 2003 to ban all forms of cloning and the use of SCNT,
but neither passed in the Senate. Almost every year we see each political
side introduce their version of a law which would outlaw all human cloning

or only reproductive cloning and either outlaw or permit the use of
embryonic stem cells, but nothing has been signed into law.

Perhaps the most interesting part of the congressional debate is the fact that
views on the topic do not necessarily follow traditional party lines or a
person's opinion on abortion or right to life. This new debate has produced
the most unlikely bipartisan partnerships and has resulted in a deadlock in
Congress, which has sharply constrained federally funded research on
embryonic stem cells and human cloning. At the same time, the deadlock
has virtually left the privately funded research involving embryonic stem
cells and human cloning completely unregulated.

Momentum for expanding federal funding for embryonic stem cell research
began to build again as the 2004 presidential campaigns kicked into gear. In
April of 2004, 206 members of the House of Representatives (out of 435)
signed a letter to President Bush urging him to expand the current federal
policy on embryonic stem cell research to include new lines developed after
August 9, 2001. Following the House’s lead, the Senators that advocated
embryonic stem cell research also wrote a letter to President Bush with 58
signatures (out of 100). On May 10, 2004 former First Lady Nancy Reagan
publicly supported embryonic stem cell research at a fundraiser for juvenile
diabetes. Although privately she had supported the research with personal
letters to congressmen, this was her first public statement on the topic.
Nancy Reagan and the Reagan family are often thought of as icons for the
Republican Party and conservative ideals. This public acceptance led the
way for other Republicans to support the issue. One month later, President
Reagan, a victim of Alzheimers, passed away. Stem cell research was
immediately brought into the forefront as a campaign issue for the 2004
election. Senator Kerry supported the expansion of the research, while the
President Bush explained his current policy and promised to maintain the
status quo.

With the return of President Bush to office in 2005, the possibility for
changing the current federal policy seems unlikely. However, in May 2005,
the U.S. House of Representatives passed the Stem Cell Research
Enhancement Act, perhaps the most significant legislative advance in the
support of stem cell research (see Table II). Its passage was the result of an

initiative from the leaders in both parties. The bill amends the Public Health
Service Act to provide for stem cell research by stating that cells donated
from excess supplies from IVF clinics are viable for use. It stipulates that
these donations are to be made from embryos determined never to be
implanted in a woman and under informed consent without any financial
inducements. The bill goes on to say that reports of research carried out
under these guidelines should be presented each fiscal year. The Stem Cell
Research Enhancement Act needed to be passed by the U.S. Senate, and
although the Senate Majority Leader, Senator Bill Frist (R-TN) promised to
bring it forward in 2005, the vote did not occur until July 2006. As he
promised in May 2005, President Bush vetoed the bill on July 19, 2006 (the
first use of the Presidential veto by Bush) and Congress was unable to
override it.

Table II-Bills from 109th Congress

Bill Sponsor Action
H.R.810 Rep Castle (R-DE} Stem Cell Research Enhancement Act.

Rep DeGette (D-CO) =‘ This bill authorizes federal funding of research on human embryonic
stem cells regardless ofthe date they were derived. All embryos must
be from donates excess from IVF clinics.

Passed in the House in May 2005.

5. 471 Sen. Specter (R-PA) Stem Cell Research Enhancement Act.
Sen. Hatch (R-UT) Companion bill to H.R. 810.

Sen. Feinstein (D-CA) Passed in the Senate July 2006.
Sen. Kennedy (D-MA)
Sen. Harkin (D-1A}

With or without the expansion of federal funding, some states (such as
California, Massachusetts, and New Jersey) are beginning to pick up the
reins by passing their own laws related to embryonic stem cell research (see
page 15 “State Cloning Legislation”). In November 2004, Californians
(with 59% of the vote) approved Proposition 71, or the California Stem
Cell Research and Cures Initiative, which called for the creation of a
California Institute for Regenerative Medicine (CIRM) and authorized $3
billion of state funds to support the effort over the next five years. The
proposal also established the right to conduct embryonic stem cell research
in California, but prohibits reproductive cloning. President Bush’s policy
only limits federal funding, but does not make the research itself illegal
therefore the states are able to determine how they wish to regulate and
fund research using state funds. CIRM supports embryonic stem cell (and

adult stem cell) research regardless of the date the cells were generated, to
create new cell lines, and to use SCNT to create cell lines with specific
genes. This new institute is expected to attract stem cell researchers and
investors to California allowing it to corner the market on any promising
findings.

Despite the passage of Proposition 71, several obstacles have delayed its
implementation in California. A lawsuit by taxpayer groups contended that
CIRM could not sell bonds backed by taxpayer money to fund research,
because it is not under direct state control. Bond sales that would be used to
fund the institute are on hold until the lawsuit is settled. In April 2006, the
court ruled in favor of CIRM, but the case is still in appeals. Furthermore,
CIRM needed time to determine the rules for awarding grants, conducting
research, and handling patent rights before it started funding grants.
However, in April 2006 CIRM was still able to award their first round of
grants, which totaled $12.1 million, and in July 2006 California Governor
Arnold Schwarzenegger agreed to give the institute a $150 million loan to
help while litigation was pending.

Summary

The debates on stem cell research essentially started in 1997, after the first
mammal, “Dolly,” was cloned. Through the past decade, the United States
government has not been able to agree on the best policy. The Bush
Administration put into place a policy that allows some research to proceed,
but at the same time it fails to address the research that is taking place with
private and other non-federal funds. Recently, Congress finally settled their
stalemate and passed legislation to increase the number of cell lines derived
from leftover IVF eggs. Unfortunately, this was vetoed, leaving the question
of regulation of this research unresolved. Whether we should fund
embryonic stem cell research and therapeutic cloning and how to regulate
the current research done with private funds are questions U.S. lawmakers
still need to address.

Example:

Effects of President Bush's Stem Cell Policy

In an effort to appease the advocates for embryonic stem cell research, but
still stay true to his conservative base, President Bush allowed federal
funding of research on human embryonic stem cells derived on or before
August 9, 2001. At the time of the announcement, the NIH believed that
there were 60-75 lines which met the qualification for federal funding.
Since the announcement, scientists have found several problems with the
cell lines which were approved:

1. Currently there are only 22 lines available for distribution by the NIH
(the other lines were unavailable for distribution). Many of the other
cell lines were either unavailable to researchers or had contamination
problems, chromosomal abnormalities, or were unstable.

2. All the cells had been created using mouse cells; therefore, they
cannot be used in humans for fear of spreading mouse viruses in
humans. It also has been shown recently that all the lines tested
contained mouse proteins on their surface which causes them to be
rejected by the immune system in a human. This means the cells are
unlikely to ever be used for medical purposes.

3. Older cell lines are more susceptible to chromosomal abnormalities
than newer lines. So over time, the current stem cell lines will degrade
and are not medically viable.

4. Several of the lines have been difficult to grow, giving them very
limited uses.

5. Each approved cell line has the propensity to grow into only one
specific cell-type. This decreases the breadth of research opportunities
for scientists.

6. The cell lines lack genetic diversity necessary to create therapeutic
treatment for a broad number of patients

7. There is an absence of disease-specific cell lines, thereby limiting
stem cell research on genetic diseases.

Improvements in how scientists can grow the cells in vitro have made new
cell lines created in other countries and from private funding (now
numbering over 150 lines) more appealing than the lines approved for
federal funding. This discourages scientists from using the cell lines,
applying for the federal funds, or even entering the field. Most scientists,

especially new faculty and graduate students, rely heavily on public
funding during their careers.

This policy also limits the availability of subsequent discoveries to the
general public. Since private firms will own any therapies derived from
such research and may charge heavily to recoup their investments, they
have no incentives to publicly release their data.

Reference and Further Suggested Readings

1. Thomas, Legislative Information on the Internet: http://thomas.loc.gov

2. American Association for the Advancement of Science. (2003)
Regulating Human Cloning. Washington D.C.: AAAS:
http://www.aaas.org/spp/cstc/briefs/cloning/index.shtml

3. California Institute for Regenerative Medicine:
http://www.cirm.ca.gov/.

4. National Research Council and Institute of Medicine. (2002) Stem
Cells and the Future of Regenerative Medicine. Washington D.C.:
National Academy Press: http://www.nap.edu.

5. National Research Council and Institute of Medicine. (2002) Scientific
and Medical Aspects of Human Reproductive Cloning. Washington
D.C.: National Academy Press: http://www.nap.edu.

6. National Research Council and Institute of Medicine. (2005)
Guidelines for Human Embryonic Stem Cell Research. Washington
D.C.: National Academy Press: http://www.nap.edu.

7. President’s Council on Bioethics. (2004), Monitoring Stem Cell
Research: http://www.bioethics. gov/reports/stemcell/index.html

8. Bonnicksen, A.L. (2002) Crafting a Cloning Policy, From Dolly to
Stem Cells. Washington D.C.: Georgetown University Press.

9. Thomson, J.A. et. al. (1998) Embryonic Stem Cell Lines Derived from
Human Blastocysts. Science 282:1145-7.Wilmut, I., et. al. (1997)
Viable Offspring Derived from Fetal and Adult Mammalian Cells.
Nature 385:810-13.

To contact us, please visit our contact page.

State Cloning Legislation

State Cloning Laws

Note:The information in this section is provided to illustrate the diversity
of approaches various states are taking with regard to regulation of human
cloning and embryonic stem cell research. The brief summary is based on a
review of relevant literature and websites and should be considered
preliminary.

Overview

While the United States has not passed any federal legislation concerning
ESC research and human cloning, individual states have started passing
their own laws. Sixteen states have legislation involving human cloning.
Arkansas, California, Connecticut, Illinois, Indiana, Iowa, Maryland,
Massachusetts, Michigan, New Jersey, North Dakota, Rhode Island, South
Dakota, and Virginia have passed legislation to prohibit reproductive
cloning. Arkansas, Indiana, Michigan, North Dakota, and South Dakota
also prohibit therapeutic cloning (cloning for research). Virginia fails to
define "human being," and so it is unclear if therapeutic cloning is banned.
Arizona, Indiana, and Michigan specifically prohibit the use of state funds
for any human cloning, while Missouri prohibits public funding for
reproductive cloning only. California, Connecticut, Illinois, Iowa,
Maryland, Massachusetts, New Jersey, and Rhode Island specifically allow
therapeutic cloning. California, Connecticut, Illinois, Maryland, and New
Jersey have also gone so far as to fund such research using state money.

Twenty-six states have no legislation addressing either cloning or
embryonic stem cell research and therefore have no policy on record.
However, almost all of these states have pending legislation. Louisiana is
the only state that bans research on IVF embryos, but this does not cover
therapeutic or reproductive cloning as long as the blastocyst comes from

another source such as being created from a sperm or unfertilized egg cell.
Thus cloning is not explicitly restricted in Louisiana.

States with Bans on Research Destroying Embryos

Louisiana, Michigan, Minnesota, North Dakota, South Dakota, and
Pennsylvania.

States with Bans on Reproductive and Therapeutic Cloning (SCNT)

Arkansas, Indiana, Michigan, North Dakota, South Dakota, and Virginia
(because ‘human being’ was left undefined in the legislation)

States with Bans Only Reproductive Cloning

California, Connecticut, Illinois, lowa, Maryland, Massachusetts, New
Jersey, and Rhode Island.

States with Bans on Public Funds

For Embryonic Stem Cell Research: Nebraska (using money from the
tobacco settlement fund only)

For Cloning: Arizona, Indiana, and Michigan

For Reproductive Cloning: Missouri

States Funding Embryonic Stem Cell Research

California (California Institute for Regenerative Medicine), Connecticut
(Connecticut Stem Cell Research Grants Program), Illinois (Illinois

Regenerative Medicine Institute), Maryland (Maryland Stem Cell Research
Fund), Massachusetts (Life Sciences Investment Fund), New Jersey (The
Stem Cell Institute of New Jersey and the New Jersey Stem Cell Research
Grants Program), Wisconsin (Stem Cell Products, Inc)

States with Restrictions Effecting Embryonic Stem Cell Research, but no Legislation on
Cloning

Nebraska, New Hampshire, Minnesota, Ohio, Oklahoma, and Pennsylvania.

States with no Legislation on either Cloning or Embryonic Stem Cell Research

Alabama, Alaska, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho,
Kansas, Kentucky, Maine, Mississippi, Montana, Nevada, New Mexico,
New York, North Carolina, Oregon, South Carolina, Tennessee, Texas,
Utah, Vermont, Washington, West Virginia, and Wyoming

References and Further Suggested Readings

1. National Conference of State Legislatures:
http://www.ncsl.org/programs/health/genetics/rt-shcl.htm,
http://www.ncsl.org/programs/health/genetics/embfet.htm and
http://www.ncsl.org/programs/health/genetics/geneticsDB.cfm

2. California Institute for Regenerative Medicine:
http://www.cirm.ca.gov/

3. Connecticut Legislature: www.cga.ct.gov/2005/BA/2005SB-00934-
RO1-BA.htm.

4. Maryland Legislature:
http://mlis.state.md.us/2006rs/bills/sb/sb0144t.pdf.

5. Illinois Governor’s Office: www.illinois. gov/gov/execorder.cfm?
eorder=39.

6. State of New Jersey: www.state.nj.us/scitech/stemcell/.

To contact us, please visit our contact page.

Overview of World Human Cloning Policies

Overview

Note:The information in this section is provided to illustrate the diversity of approaches various
different parts of the world are taking with regard to regulation of human cloning and embryonic stem
cell research. The brief summary is based on a review of relevant literature and websites and should be
considered preliminary.

World policies on human or reproductive cloning range from complete prohibition to no policies on
record. Over 30 countries, including France, Germany, and the Russian Federation, have banned human
cloning altogether. Fifteen countries, such as Japan, the United Kingdom, and Israel, have banned
human reproductive cloning, but permit therapeutic cloning. A few countries such as Hungary and
Poland do not explicitly prohibit embryonic stem cell research or therapeutic cloning, partially because
their legislation was drafted before embryonic stem cells were first produced (1998). Many other
countries, similar to the United States, have yet to pass any official legislation concerning human
cloning allowing all types of stem cell and cloning research to occur.

In addition to countries developing their own policies, several international organizations, including the
United Nations, the Council of Europe, and the European Union, have published human cloning
policies and recommendations, which are described below. Several other organizations including the
African Union and the Arab Leagues have discussed the issue, but have yet to release a formal
declaration. Furthermore, the International Society for Stem Cell Research (ISSCR) and a group led by
Johns Hopkins Phoebe R. Berman Bioethics Institute, known as the Hinxton Group, are working to
outline principles for human embryonic stem cell international collaboration and cooperation.

ESC* Ther. Ban** ESC Ther. Ban**
Argentina x x Latvia x x
Australia x x Lithuania x
Austria x Netherlands x x
Bees ‘ . pee . .
Brazil x x Norway x
Canada x x Panama x x

Chile x x Peru x x

China x x Poland

Columbia x x Portugal
Costa e Russian
Rica Federation
Czech :
Republic x x Singapore
Denmark x x Slovakia
Ecuador x Slovenia
South
Egypt * ? Africa
Estonia x x South
Korea
Finland x x Spain
France x x Sweden
Georgia x x Switzerland
Germany x x Taiwan
Greece x x Thailand
aaa e Trinidad &
Bary Tobago
Iceland x x Tunisia
India x Turkey
Iran x Ukraine
United
Ireland x Kingdom
sal . . United
States
Italy x Uruguay
Japan x x Vietnam

World Cloning Legislature

*Some prohibit the derivation of embryonic stem cells, but do not specifically prohibit the research
using existing lines.

**Ban refers to countries which banned human cloning (both reproductive and therapeutic).

United Nations

On March 8, 2005, the United Nations General Assembly adopted the nonbinding ‘Declaration on
Human Cloning’, by which member states were called on to adopt "all measures necessary to prohibit
all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of
human life." The vote was 84 in favor (including United States, Germany, and Italy), 34 against
(including United Kingdom, South Korea, and Brazil), 37 abstaining (including South Africa and Israel)
and 35 were absent. This Declaration is arguably weakened by the fact that it was not even passed by a
majority of the UN membership.

Many countries, in formal explanations of their votes, expressed disappointment that there was no
consensus on the language of the declaration and said that it was regrettable that it did not cover the
well-known differences between reproductive cloning and therapeutic cloning (somatic cell nuclear
transfer). The original mandate to the Legal Committee was to elaborate on the issue in an international
treaty against human reproductive cloning. Instead, text of the declaration blurred the line separating
reproductive and therapeutic cloning.

Council of Europe

The Council of Europe is an international organization of 46 countries in Europe, which was established
in 1949. The Council was set up to defend human rights and democracy, develop continent-wide
agreements to standardize social and legal practices and promote European interests. Membership to the
Council is open to all European democracies, which accept the principle of the rule of law and
guarantee fundamental human rights and freedoms to their citizens.

The Council of Europe has several conventions that can be applied to human embryonic stem cell
research and human cloning. The Council’s 1997 Convention on Human Rights with Regard to
Biomedicine highlights the “need to respect the human being both as an individual and as a member of
the human species.” The protocol on cloning states that “any intervention seeking to create a human
being genetically identical to another human being, whether living or dead is prohibited.” While this
specifically bans reproductive cloning it does not necessarily ban therapeutic cloning. The Council left
the interpretation of ‘human being’ to national Parliaments, allowing therapeutic cloning where it is
accepted. In several European countries without specific stem cell or cloning legislation (Bulgaria,
Croatia, Cyrus, Moldova, Romania, and San Marino) this convention is interpreted to mean that they
allow human embryonic stem cell cloning, but ban both reproductive and therapeutic cloning.

European Union

The European Union is an intergovernmental and supranational union containing 25 member states
from Europe. It was established in 1950 by six countries (Belgium, France, Germany, Italy,
Luxembourg, and the Netherlands) and dealt with economic and trade issues. It now has an additional
19 member states (Denmark, Ireland, United Kingdom, Greece, Portugal, Spain, Austria, Finland,

Sweden, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia,
Slovenia) for a total of approximately 450 million people and deals with a wide range of issues
including health, the environment, and international peace and stability.

The European Union supports funding embryonic stem cell research (where permitted), but has banned
the funding of human cloning. There is no legal ban on therapeutic cloning, but the European Union
will not fund research using SCNT to create embryos. It allows for countries to determine within their
border what embryonic stem cell research can be funded allowing that it is carefully regulated, peer
reviewed, scientifically sound, directed towards sustainable goals, and ethically sound.

References and Further Suggested Readings

1. The Database of Global Policies on Human Cloning and Germ-line Engineering:
http://www. ¢lphr.org/genetic/genetic.htm
2. Global Lawyers and Physician for Human Rights: http://www.g|phr.org
. Stem Cell Policy: World Stem Cell Map: www.mbbnet.umn.edu/scmap.html
4. European Commission, Directorate General — Research: Survey on opinions from National Ethics
Committees or similar bodies, public debate, and national legislation in relation to human
embryonic stem cell research and use. Volume I: EU Member States, July 2004:
http://www.europa.eu.int/comm/research/biosociety/bioethics/documents_en.htm, Volume II:
Countries associated to FP6 and Third Countries, July 2004:
http://www.europa.eu.int/comm/research/biosociety/bioethics/documents_en.htm
. UNESCO (United Nations Educational, Scientific, and Cultural Organization). National
Legislation Concerning Human Reproductive and Therapeutic Cloning, July 2004:
http://unesdoc.unesco.org/images/0013/001342/134277e.pdf
6. The International Stem Cell Forum (May 2007) http://www.stemcellforum.org
The Hinxton Group World Policies Website (May 2007): http://hinxtongroup.org/wp.html
. The Hinxton Group Consensus Statement, March 2006:
http://www.hopkinsmedicine.org/bioethics/finalsc.doc.
9. The Phoebe R. Berman Bioethics Institute. (March 2006) International Policy Trends: Embryonic
Stem Cell Research.

w

uo

oN

To contact us, please visit our contact page.

World Cloning Policies
North America

United States

¢ Officially, embryonic stem cell research, therapeutic cloning and
reproductive cloning are legal as there is currently no federal
regulation or policies overseeing it.

e Reproductive and therapeutic cloning are specifically not federally
funded. However, research on human embryonic stem cells is federally
funded if these cell lines were created before August 9, 2001. Private
industry research is not affected by these policies and is allowed to
proceed with the creation of new stem cell lines.

e Some individual states have made their own laws against reproductive
and/or therapeutic cloning. (See State Cloning Legislation module)

Canada

e Embryonic stem cell research is permitted, but reproductive cloning
and therapeutic cloning are banned.

e Researchers can use an embryo from IVF if it is no longer needed for
reproductive purposes and consent is given by the donor. Creating a
human clone is restricted to improving or providing instruction in
assisted reproduction procedures.

Costa Rica

e Embryonic stem cell research, as well as therapeutic and reproductive
cloning, is banned.

e Any manipulation of an embryo's genetic code is prohibited, as well as
any experimentation on the embryo (two laws as of 1995 and 1998).

Panama

e Embryonic stem cell research is not specifically prohibited, but
therapeutic and reproductive cloning and the funding of such activities
are as of 2004.

Trinidad and Tobago

e Embryonic stem cell research as well as therapeutic and reproductive
cloning is banned.

e The law states that the manipulation of ovum, zygotes, and/or
embryos for the purpose of producing one that is genetically
equivalent to a living or deceased human being, embryo, zygote, or
fetus -- or implantation of this -- is prohibited. The ovum may not be
retrieved to be fertilized, to mature outside of the human body, or to be
implanted (as of 1999).

El Salvador

e Embryonic stem cell research as well as therapeutic and reproductive
cloning is banned.

South America

Argentina

e Embryonic stem cell research is permitted, but all forms of cloning
(reproductive and therapeutic) are banned.

e The law specifically states that experiments concerning cloning of
human cells in order to generate human beings are prohibited.

Brazil

e Embryonic stem cell research is allowed on IVF embryos that have
been frozen for at least three years. Therapeutic cloning and
reproductive cloning are banned (Bio-Safety Law, March 24, 2005).

Chile

e Embryonic stem cell research is not specifically prohibited, but
therapeutic and reproductive cloning and the funding of such activities
are.

e The law states that the cloning of human beings and interventions
which results in the creation of a human being genetically identical to
another is prohibited.

Columbia

e Embryonic stem cell research and therapeutic cloning are permitted,
but reproductive cloning is banned.

e The criminal code (2000) prohibits fertilization of a human ovum with
intent other than procreation and prohibits genetic manipulation for the
purpose of reproductive cloning. The code does allow the fertilization
of human ova for research and diagnostic purposes, if there is a
therapeutic goal.

Ecuador

e Embryonic stem cell research as well as therapeutic and reproductive
cloning is banned.

e Research on human embryos (and therefore cloning) is prohibited as of
June 1998.

Peru

e Embryonic stem cell research is not specifically prohibited, but
therapeutic and reproductive cloning are banned.

e Fertilization of a human ovum with intent other than procreation is
prohibited, as well as human cloning (General Health Law, 1997).

Uruguay

e Embryonic stem cell research and therapeutic cloning are not
specifically prohibited, but reproductive cloning is.

Europe

Austria

e Embryonic stem cell research as well as therapeutic and reproductive
cloning is banned.

¢ Reproductive medicine is acceptable only within stable heterosexual
relationships for the purpose of reproduction. Embryos can be used
only for implantation in the woman who has donated the oocytes, and
for no other purposes. Donation of embryos or gametes is prohibited
(Federal Law of 1992 Regulating Medically Assisted Procreation).

Belgium

e Embryonic stem cell research and therapeutic cloning are permitted,
but reproductive cloning is banned as of May 2003.

Czech Republic

e Embryonic stem cell research is permitted using lines created from
unused IVF eggs.

Denmark

e Embryonic stem cell research is not specifically prohibited, but
therapeutic and reproductive cloning and the funding of such activities
are as of 2003.

Estonia

e Embryonic stem cell research is allowed, but reproductive and
therapeutic cloning are banned.

Finland

e Embryonic stem cell research and therapeutic cloning are permitted,
but reproductive cloning is banned.

e The act defines embryo as a fusion of gametes, so therapeutic cloning
is permitted, but reproductive cloning is prohibited (Medical Research
Act of 1999).

France

e Embryonic stem cell research is allowed, but therapeutic and
reproductive cloning are banned.

e Research on human embryonic stem cells is now allowed until
embryos are 6-8 days old. Embryos cannot be created specifically for
research -- scientists must use existing embryos from IVF. Embryonic
stem cell lines are typically imported from abroad.

Georgia

e Embryonic stem cell research is not specifically prohibited, but
therapeutic and reproductive cloning are.

e¢ Human cloning through the use of genetic engineering is prohibited
(1997 Law on Health Care).

Germany

e Embryonic stem cell research is permitted, but all forms of cloning
(reproductive and therapeutic) are banned.
e It is Illegal to create any new stem cell lines after December 2001.

Greece

e Embryonic stem cell research is permitted, but reproductive cloning is
banned.

Hungary

e Embryonic stem cell research is not specifically prohibited, but
reproductive and therapeutic cloning are.

e The national law (1997) does not explicitly address or prohibit
embryonic stem cell research or therapeutic cloning.

Iceland

e Embryonic stem cell research is permitted using lines created from
unused IVF eggs and for development or fertility research.

e Reproductive and therapeutic cloning are prohibited (Act on Artificial
Fertilisation, 1996).

Ireland

e Embryonic stem cell research as well as therapeutic and reproductive
cloning is banned.

¢ Human cloning is prohibited because the "right to life of an unborn
child is equal to that of the mother" as stated in the Constitution of
Ireland.

Italy

e Embryonic stem cell research, as well as therapeutic and reproductive
cloning are banned.

Latvia

e Embryonic stem cell research is permitted, but therapeutic and
reproductive cloning are prohibited, as of the 2002 Law on Sexual and
Reproductive Health.

Lithuania

e Embryonic stem cell research as well as therapeutic and reproductive
cloning are prohibited.

e Human embryos may be subjects only of clinical observations (non-
invasive investigations).

The Netherlands

e Embryonic stem cell research is permitted, but all forms of cloning
(reproductive and therapeutic) are banned.

e There is a five year moratorium (ending in 2007) prohibiting
therapeutic cloning.

Norway

e Embryonic stem cell research, as well as therapeutic and reproductive
cloning is banned.

e Research on embryos and the use of techniques aimed at the
production of genetically identical individuals is prohibited (The
Medical Use of Biotechnology, 1995).

Poland

e Human reproductive cloning and embryonic research are specifically
prohibited.
e Human embryos may not be used for non-therapeutic research.

Portugal

e Embryonic stem cell research is permitted, but reproductive cloning is
banned and therapeutic cloning is implicitly prohibited.

e The law states that the cloning of human beings is prohibited (National
Council of Ethics for the Life Sciences, 1997).

Russian Federation

e Embryonic stem cell research is not specifically prohibited, but
therapeutic and reproductive cloning are.

e For a five-year period starting in 2002, human cloning is prohibited, as
well as the import and export of human cloned embryos (Law on
Temporary Prohibition of Human Reproductive Cloning, 2002).

Slovakia

e Embryonic stem cell research as well as therapeutic and reproductive
cloning are banned.

Slovenia

e Embryonic stem cell research is not specifically prohibited, but
therapeutic and reproductive cloning are.

e Human cloning for reproductive and therapeutic purposes is prohibited
by the Law on Medically Assisted Reproduction (2000) and the Penal
Code (2002).

Spain

e Embryonic stem cell research is permitted, but reproductive and
therapeutic cloning are banned.

e Any therapeutic intervention, investigation, or research activity in pre-
embryos in vitro, pre-embryos, or embryos and fetuses in utero will be
authorized only if it does not alter the genetic makeup of the embryo,
and as long as it is not aimed at one particular individual or race-
selection. Research on in vitro embryos is allowed with parental
consent, after the embryos have been frozen for five years or more.

Sweden
e Embryonic stem cell research and therapeutic cloning are permitted,

but reproductive cloning is banned. (Act 1991/115 and Government
Bill 2003/04:148)

Switzerland

e Embryonic stem cell research is allowed on excess stocks of embryos
produced naturally for artificial insemination.
e Therapeutic and reproductive cloning are banned.

Turkey

e Embryonic stem cell research is not specifically prohibited.
e Therapeutic cloning is allowed, but reproductive cloning is not (as of
1996).

Ukraine

e Embryonic stem cell research and therapeutic cloning are not
specifically permitted, but reproductive cloning is banned.

United Kingdom

e Embryonic stem cell research and therapeutic cloning are permitted,
but reproductive cloning is banned.

e Therapeutic cloning is regulated by Human Fertilization and
Embryology Authority (HFEA) in order to understand the
development of embryos and to develop treatments for serious disease.

Asia

China

e Embryonic stem cell research and therapeutic cloning are permitted,
but reproductive cloning is banned.

¢ "Guidelines for Research on Human Embryonic Stem Cells" released
in 2004 by China's Ministry of Science and Technology, and Ministry
of Health.

India

e Embryonic stem cell research and therapeutic cloning are permitted,
but reproductive cloning is banned.

e The Indian Council of Medical Research released the Consultative
Document on Ethical Guidelines for Biomedical Research on Human
Subjects (2000), which cover the guidelines.

Japan

e Embryonic stem cell research and therapeutic cloning are permitted,
but reproductive cloning is banned.

e Production of cloned human embryos will be limited to basic research
or regenerative medicine only (Bioethics Committee of the Council for
Science and Technology Policy).

Singapore

e Embryonic stem cell research and therapeutic cloning are permitted,
but reproductive cloning is banned.

e The law allows the harvesting of stem cells from cloned human
embryos, but it prohibits cloned embryos from developing more than
two weeks.

South Korea (Republic of Korea)

e Embryonic stem cell research and therapeutic cloning are permitted,
but reproductive cloning is banned.

e The government approved research on somatic cell nuclear transfer
based on guidelines of National Ethics Committees.

Taiwan (Republic of China)

e Embryonic stem cell research is allowed on excess stocks of embryos
produced naturally for artificial insemination.

e Reproductive and therapeutic cloning are banned, as is the creation of
embryos for research purposes.

Thailand

e Embryonic stem cell research and therapeutic cloning are permitted,
but reproductive cloning is banned.

Vietnam

e Embryonic stem cell research is not specifically prohibited, but
therapeutic and reproductive cloning are.
e Human cloning and surrogacy banned as of May 2003.

Oceania

Australia

e Embryonic stem cell research and therapeutic cloning are permitted,
but reproductive cloning is banned.
e Researchers must apply for a license to experiment with embryos

New Zealand

e Embryonic stem cell research and therapeutic cloning are permitted,
but reproductive cloning is banned.

e In 2004, the Human Assisted Reproductive Technology Bill was
amended to ban reproductive cloning and genetically engineered

babies.
Middle East

Egypt
e Bans reproductive cloning and potentially therapeutic cloning.

e The researcher is prohibited from conducting research involving
mixing lineages.

Iran

e Embryonic stem cell research is permitted.

Israel

e Embryonic stem cell research and therapeutic cloning is permitted, but
reproductive cloning is banned.

e Human reproductive cloning and germline genetic engineering is
prohibited.

Africa

South Africa

e Embryonic stem cell research is permitted, but all forms of cloning
(reproductive and therapeutic) are banned.

Tunisia

Embryonic stem cell research is not specifically prohibited, but
therapeutic and reproductive cloning are as of 1997.
The law states that any technology related to human cloning is banned.

References and Further Suggested Readings

1.

2,

ey

The Database of Global Policies on Human Cloning and Germ-line
Engineering: http://www.g|phr.org/genetic/genetic.htm

Global Lawyers and Physician for Human Rights:
http://www.g|phr.org

Stem Cell Policy: World Stem Cell Map:
www.mbbnet.umn.edu/scmap.html

. European Commission, Directorate General — Research: Survey on

opinions from National Ethics Committees or similar bodies, public
debate, and national legislation in relation to human embryonic stem
cell research and use. Volume I: EU Member States, July 2004:
http://www.europa.eu.int/comm/research/biosociety/bioethics/docume
nts_en.htm, Volume II: Countries associated to FP6 and Third
Countries, July 2004:
http://www.europa.eu.int/comm/research/biosociety/bioethics/docume
nts_en.htm

. UNESCO (United Nations Educational, Scientific, and Cultural

Organization). National Legislation Concerning Human Reproductive
and Therapeutic Cloning, July 2004:
http://unesdoc.unesco.org/images/0013/001342/134277e.pdt

. The International Stem Cell Forum (May 2007)

http://www.stemcellforum.org

. The Hinxton Group World Policies Website (May 2007):

http://hinxtongroup.org/wp.html

. The Hinxton Group Consensus Statement, March 2006:

http://www. hopkinsmedicine.org/bioethics/finalsc.doc,

. The Phoebe R. Berman Bioethics Institute. (March 2006) International

Policy Trends: Embryonic Stem Cell Research.

To contact us, please visit our contact page.

Glossary

Alphabet

Glossary

Adult Stem Cells
An unspecialized or undifferentiated cell found among specialized
cells in a tissue or organ, which can renew itself and differentiate into a
specialized cell.

Autoimmune Disease
A disease where one own body starts attacking itself and destroying
itw own cells.

&-cell
A cell in the pancreas which is responsible responsible for the
production and regulation of insulin.

Blastocyst
A pre-implanted embryo of 30-150 cells that is 5-6 days old.

Cell-Based Therapies
Treatment in which stem cells are induced to differentiate into the
specific cell type required to repair damaged or depleted adult cell
populations or tissues.

Characterizing Stem Cells
Determining how a cell grows, where the cell came from, how it was
derived, and if there are any chromosomal abnormalities.

Cloning
In biology, it is the act of producing an exact copy of a sequence of
DNA, cell, tissue, or organism.

Department of Human and Health Services (DHHS)
The United States government's principal agency for protecting the
health of all Americans. It provides essential human services,
especially for those who are least able to help themselves.

Deriving
The creation of a cell line from one original cell or set of cells.

Differentiation
The process of unspecialized cells transforming into specialized cells.

Embryo
In humans, the developing organism from the time of fertilization until
the end of the eighth week, when it becomes known as a fetus.

Embryonic Stem Cell
An unspecialized or undifferentiated cell found in the inner cell mass
of a blastocyst, which can renew itself and differentiate into a
specialized cell.

Endoderm
The internal layer of cells of an embryo; eventually gives rise to the
digestive tract, lungs, and associated structures.

Fetus
A developing human from the eighth week after fertilization to birth.

Gamete
A mature sexual reproductive cell (sperm or egg) having a single set of
unpaired chromosomes.

Hematopoetic Stem Cell
An adult stem cell from which all white and red blood cells evolve.

Human Fertilisation and Embrology Authority (HFEA)
The governmental authority in the United Kingdom that regulates in
vitro fertilization and embryo research.

Inner Cell Mass
A small group of about 30 cells in a blastocyst which will give rise to
the hundreds of highly specialized cells needed to make up an adult
organism; embryonic stem cells are derived from this group.

Insulin
A hormone in the body that balances blood sugar levels.

In Vitro
From the Latin for "in glass"; in a laboratory dish, test tube, or
artificial environment.

In Vitro Fertilization (IVF)
An assisted reproduction technique in which fertilization is
accomplished outside the body.

In Vivo
In the living subject; the natural environment.

Juvenile Diabetes
Also known as type 1 diabetes, it is an autoimmune disease where the
{-cells in the pancreas are destroyed and therefore the individual loses
some or all of his/her ability to regulate and produce insulin. If left
untreated, it can have severe side effects such as kidney failure,
blindness, stroke and even death.

National Bioethics Advisory Council (NBAC)
A committee of experts during the Clinton administration that was
formed in 1995 to provide advice and make recommendations to
appropriate government entities related to bioethical issues. Their
charter expired in October 2001.

National Institutes of Health (NIH)
An agency of the Department of Human and Health Serves, its mission
is the pursuit of knowledge about nature and behavior of living
systems. It provides leadership and direction to programs designed to
improve health by conducting and supporting research: in the causes,
diagnosis, prevention, and cure of human diseases; in the processes of

human growth and development; in the biological effects of
environmental contaminants; in the understanding of mental, addictive
and physical disorders; in directing programs for the collection,
dissemination, and exchange of information in medicine and health,
including the development and support of medical libraries and the
training of medical librarians and other health information specialists.

Nucleus
A structure within a living cell that contains the cell’s DNA and
controls its metabolism, growth, and reproduction.

Oocyte
A female cell that develops into an ovum (egg) after meiosis; an egg
before maturation.

Ovum
The female reproductive cell or egg (plural is ova).

Pluripotent
The ability of a single cell to develop into many different cell types of
the body.

President's Council on Bioethics (PCB)
A committee of experts during the Bush administration that was
formed in 2001 (after the NBAC was disbanded) to provide the
President with advice on bioethical issues that may emerge as a result
of biomedical science and technology.

Proliferation
Expansion of a population of cells by the continuous division of single
cells into two identical cells.

Quiescent
A cell that does not divide or replicate.

Reproductive Cloning
When an egg undergoes somatic cell nuclear transfer and the resulting
cell is allowed to grow to an infant that is an exact copy of the donor.

Signals
Internal and external factors that control the changed in cell structure
and function.

Smooth Muscle
Also known as “involuntary muscle,” these muscles perform automatic
tasks such as peristalsis and blood vessel constriction. Named smooth
muscle because of smooth, rather than striated, appearance under a
microscope.

Somatic Cell
Any cell of a plant or animal other than the germ (sperm or egg) cell.

Somatic Cell Nuclear Transfer (SCNT)
When the genetic material (nucleus) of an egg is removed and replaced
with the genetic material of a normal cell.

Stem Cell
An unspecialized cell that can replicate itself for indefinite periods
through cell division and under certain conditions becomes a
specialized cell.

Therapeutic Cloning
When embryonic stem cells created by somatic cell nuclear transfer
are studied in vitro and used for cell-based therapies, but never are
implanted in a female or grown past 14 days.

Undifferentiated Cell
A primitive cell that does not have any tissue-specific structures that
allows it to perform specialized functions. It has not changed to
become a specialized cell.

Zygote
The cell (and the organism that develops from the cell) resulting from
the union of an ovum and spermatozoon (also referred to as a fertilized
ovum).

Contact Us

Contact Us

Please feel free to contact us regarding questions about the reference
materials.

Science and Technology Policy Program

Kirstin Matthews, Ph.D. James A. Baker III
Institute for Public Policy Rice University 6100
Main Street, MS-40 Houston, TX 77005

Email: stpolicy@rice.edu

Website:http://www.science.bakerinstitute.org and
http://www.ruf.rice.edu/~neal/stemcell